Site Activation Manager

This is a fully remote position, open to applicants in Australia.

📋 Description

• Act as the main point of contact and accountability for the initiation and ongoing activities of studies.

• Supervise the activities of functional groups involved in site activation to ensure that essential activities are completed on schedule and within budget.

• Gather, manage, monitor, and assess site activation activities.

• Assist with feasibility studies and site identification tasks as required.

• Accelerate the Site Qualification and Selection processes.

• Convey the status of Site Activation and Regulatory projects to sponsors and project teams.

• Create risk assessments and develop mitigation strategies.

• Ensure that study activities are accounted for in work order budgets and monitor out-of-scope activities through change orders.

• Develop and sustain site activation project plans.

• Contribute to the development of SOPs, best practice guidelines, training, and coaching initiatives.

• Provide input for departmental process enhancement efforts.

• Establish and analyze site activation metrics to implement corrective actions and meet KPIs.

• Assist business development through proposal submissions and bid defense meetings.

• Report and escalate issues to leadership to address risks and safeguard deliverables.

• Adhere to SOPs, ICH GCP, and relevant regulations.

• Coordinate with functional contributors and vendors.

• Perform additional duties as assigned.

⛳️ Requirements

• A minimum of a four-year college degree with a major in medical, biological, physical, health, pharmacy, or a related field OR a two-year college degree or equivalent education/training (nursing degree or equivalent life science degree) along with experience in clinical research (e.g., CRA, Regulatory Affairs).

• At least 4 years of experience in the CRO/pharmaceutical industry, ideally in Start-up Management, Project Management, and/or Site Management.

• Skilled in cross-cultural communication.

• Proficient in both spoken and written English.

• Excellent leadership and organizational management abilities.

• Capable of exercising sound judgment and making independent decisions.

• Ability to inspire, lead, and engage a team effectively.

• Strong interpersonal, verbal, and written communication skills.

• Familiarity with regulatory processes and guidelines.

• Knowledge of the initiation, planning, and execution of clinical projects and overall project management.

• Awareness of ICH GCP Guidelines and FDA/EU Clinical Trials Directives/National regulations.

• Ability to manage multiple tasks in a dynamic and rapidly changing environment.

• Capacity to work in an organized, systematic, and self-driven manner.

• Proficient in Microsoft Word, Excel, PowerPoint, and digital systems.

🏝️ Benefits

• Equal employment opportunity employer.

• Diverse and inclusive work environment.

• Collaboration and creativity-focused workplace.